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Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

Primary Purpose

Convulsion, Non-Epileptic

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReACT
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convulsion, Non-Epileptic

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 9-18 years old.
  • Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
  • Family member (parent if a minor) willing to participate and that the subject with PNES chooses.

Exclusion Criteria:

  • Comorbid Epilepsy
  • Less than 4 PNES per month
  • Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
  • Participation in other therapy
  • Severe intellectual disability
  • Severe mental illness (delusions/hallucinations)

Exclusion for CPT:

  • Blood pressure >130/80 mmHg for adolescents greater than or equal to 13 years old
  • Either systolic and/or diastolic blood pressure greater than or equal to 95% based on sex and age for children less than 13 years old

Sites / Locations

  • Sparks Center Office of Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

CPT- Pain relief lotion

CPT- Pain sensitivity lotion

ReACT for PNES- Booster therapy sessions

ReACT for PNES- No Booster therapy sessions

Healthy Control

Arm Description

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.

After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.

After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.

Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.

Outcomes

Primary Outcome Measures

Magic and turbulence task
Measure of perceived sense of control in response to tasks in which control is manipulated; Greater negative numbers indicate improved understanding of control. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Pain catastrophizing scale for children- situation specific
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Pain tolerance (time)
Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Salivary cortisol response to Cold Pressor Test
Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Pain Rating Scale
Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Stroop task
Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).

Secondary Outcome Measures

PNES Frequency
Measured by Psychogenic Non-epileptic Seizures (PNES) diary, including frequency, premonitory symptoms, description of PNES symptoms and duration. Assessed 30 days before treatment to 12 months after the 12th treatment session (about 16 months total). Frequency and severity also measured by Respironics Actiwatch Spectrum Pro. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Pain Catastrophizing Scale for Children (PCS-C)- General
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done before performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Children's Somatic Symptoms Inventory (CSSI-24)
General somatic symptom complaints, higher scores indicate greater somatic complaints. Scores range from 0-140. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Anxiety Sensitivity Index (ASI)
Assesses catastrophic symptom expectations; higher scores indicate greater anxiety. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Shipley
Assesses verbal IQ; higher scores indicate greater verbal IQ. Completed by participant at the baseline visit.
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
Assesses health-related quality of life for children with epilepsy (used in PNES participants by instructing them to consider their PNES when asked about "seizures"); score ranges from 0-100, higher scores indicate better functioning and well-being. Completed by participant. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Sense of Agency Scale
Single question which asks "How much control do you believe you have over your PNES?". Completed by participant. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire Physical Symptoms
Measures symptom severity in children; higher scores indicate greater symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Functional Disability Inventory (FDI)
Completed by child and parent to measure physical functioning and disability in children with chronic pain; score ranges from 0-60, higher scores indicate greater perceived functional disability. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
The Impact on Family Scale
Assesses parental perceptions of the impact of a child's medical condition on the family; higher scores indicate greater financial burden on the family. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Childhood Trauma Questionnaire
History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect. Completed by participant at baseline visit.
The Revised Children's Anxiety and Depression Scale (RCADS)
Measures anxiety and depression symptoms in children; higher scores indicate increased symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
The Columbia Suicide Severity Rating Scale (C-SSRS)
Measure that addresses the full range of suicidal thoughts and behaviors that suggest a person is at heightened risk of committing suicide. Completed by trained research study coordinator. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Healthcare Related Stigma Questionnaire
Measures stigma in patients and their parents related to their interaction with health care providers; higher scores indicate greater stigma. Completed by participant and parent. Assessed at baseline visit.
COVID-19 Functional Neurological Disorders (FND) Questionnaire
Assesses the effect of COVID-19 diagnosis in FND patients. Completed by Children. Assessed at baseline visit
Flanker Inhibitory Control and Attention Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures executive function and attention; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
List Sorting Working Memory Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures working memory; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Pattern Comparison Processing Speed Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures processing speed; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Dimensional Change Card Sort Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures executive function; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Picture Sequence Memory Subtest
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures episodic memory; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Sleep
Objectively measured using Respironics Actiwatch Spectrum Pro and subjectively measured using sleep diaries. Worn/completed by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
PNES Episode Severity
Objectively measured using Respironics Actiwatch Spectrum Pro. Worn by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).

Full Information

First Posted
October 15, 2021
Last Updated
May 19, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05096273
Brief Title
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Official Title
Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Pediatric Psychogenic Non-epileptic Seizures (PNES)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session, 7 days after 12th treatment session, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.
Detailed Description
PNES participants and their parent come to our laboratory for a baseline visit, 4 follow-up visits and 12 therapy sessions. Half of the participants will be randomized to receive 2 booster therapy sessions. Participants must provide EEG results indicating a diagnosis of psychogenic non-epileptic seizures. During the initial visit, participants and their parent will complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They will also complete the childhood trauma questionnaire. The treatment targets (sense of control and catastrophic symptom expectations), will be measured by the magic and turbulence computer task and pain tolerance, PCS-C and cortisol response to the CPT, respectively. After completing the CPT, participants will be randomized to receive a pain relief lotion or a pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand. PNES diaries will be completed to assess PNES frequency over the previous 30 days. The baseline lab visit will last about 3 hours. Saliva will be collected over 3 time points before and after each CPT to measure cortisol response to the CPT. Participants will also collect 2 saliva samples 24 hours later to serve as a baseline outside of the laboratory setting. Participants will also be given a Respironics Actiwatch Spectrum Pro to track sleep and PENS episode severity and frequency for the 1 week between the baseline visit and first ReACT session. All participants will then be scheduled to return in one week for their first of 12 sessions of ReACT. Before beginning the first ReACT session, participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests. This first session will last a maximum of two hours, and the following 11 sessions will be scheduled weekly and will each last one hour. The following 11 sessions are currently conducted via telehealth due to COVID-19. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 11th therapy session to track sleep and PENS episode severity and frequency for the 2 weeks between the 11th therapy session and the lab visit one week after the 12th treatment session. To assess treatment dose, participants will return for post lab visits one week after the 8th treatment session and 12th treatment sessions to perform tasks and fill out questionnaires completed at baseline. Long-term follow-up at 6 months and 12 months after treatment will also be conducted to perform tasks and complete follow-up assessment of the targets (sense of control and catastrophic symptom expectations), FS frequency and questionnaires. Participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests at the lab visit after the 12th treatment session and 6- and 12-month long-term follow-up visits. Each of these sessions will last 2 hours. PNES frequency will be measured from 30 days before treatment to 12 months after treatment through PNES diaries completed by the parent and the participant. After treatment, half of the participants will be randomized to receive 2 booster therapy sessions at 3 months and 9 months after the end of treatment. Each of these sessions will last one hour. Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. Healthy controls and their parent come for a baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. The baseline and follow-up appointments for healthy controls will be identical to the visits for children with PNES.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convulsion, Non-Epileptic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children with PNES and matched controls will be prospectively enrolled.
Masking
InvestigatorOutcomes Assessor
Masking Description
Researchers who conduct baseline and follow-up visits will be blinded to the condition (booster or no booster) to which the patient has been assigned. The statistician and data manger will be blinded to treatment condition when analyzing data. The PI and therapists will be blinded to participant's baseline target scores.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPT- Pain relief lotion
Arm Type
Experimental
Arm Description
During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectations. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.
Arm Title
CPT- Pain sensitivity lotion
Arm Type
Experimental
Arm Description
During the initial visit participant will do the cold pressor test twice to assess catastrophic symptom expectation. After completing the 1st CPT, participants will be randomized to receive a pain relief lotion or pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand.
Arm Title
ReACT for PNES- Booster therapy sessions
Arm Type
Active Comparator
Arm Description
After completing the 12 therapy sessions, half of the participants will be randomized to receive 2 booster therapy sessions, 3 months and 9 months after the 12th ReACT treatment session.
Arm Title
ReACT for PNES- No Booster therapy sessions
Arm Type
Experimental
Arm Description
After completing the 12 ReACT treatment sessions, half of the participants will be randomized to not receive the 2 booster therapy sessions.
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. Healthy controls and their parent come for 1 baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. These visits will be identical to baseline and follow-up visits of children with PNES.
Intervention Type
Behavioral
Intervention Name(s)
ReACT
Other Intervention Name(s)
Retraining and Control Therapy
Intervention Description
ReACT is a novel cognitive behavioral treatment and is a PNES intervention that targets sense of control and catastrophic symptom expectations
Primary Outcome Measure Information:
Title
Magic and turbulence task
Description
Measure of perceived sense of control in response to tasks in which control is manipulated; Greater negative numbers indicate improved understanding of control. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Pain catastrophizing scale for children- situation specific
Description
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Pain tolerance (time)
Description
Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Salivary cortisol response to Cold Pressor Test
Description
Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Pain Rating Scale
Description
Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Stroop task
Description
Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Secondary Outcome Measure Information:
Title
PNES Frequency
Description
Measured by Psychogenic Non-epileptic Seizures (PNES) diary, including frequency, premonitory symptoms, description of PNES symptoms and duration. Assessed 30 days before treatment to 12 months after the 12th treatment session (about 16 months total). Frequency and severity also measured by Respironics Actiwatch Spectrum Pro. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
16 months
Title
Pain Catastrophizing Scale for Children (PCS-C)- General
Description
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done before performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Children's Somatic Symptoms Inventory (CSSI-24)
Description
General somatic symptom complaints, higher scores indicate greater somatic complaints. Scores range from 0-140. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Anxiety Sensitivity Index (ASI)
Description
Assesses catastrophic symptom expectations; higher scores indicate greater anxiety. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Shipley
Description
Assesses verbal IQ; higher scores indicate greater verbal IQ. Completed by participant at the baseline visit.
Time Frame
At baseline
Title
Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)
Description
Assesses health-related quality of life for children with epilepsy (used in PNES participants by instructing them to consider their PNES when asked about "seizures"); score ranges from 0-100, higher scores indicate better functioning and well-being. Completed by participant. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Sense of Agency Scale
Description
Single question which asks "How much control do you believe you have over your PNES?". Completed by participant. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire Physical Symptoms
Description
Measures symptom severity in children; higher scores indicate greater symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Functional Disability Inventory (FDI)
Description
Completed by child and parent to measure physical functioning and disability in children with chronic pain; score ranges from 0-60, higher scores indicate greater perceived functional disability. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
The Impact on Family Scale
Description
Assesses parental perceptions of the impact of a child's medical condition on the family; higher scores indicate greater financial burden on the family. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Childhood Trauma Questionnaire
Description
History of physical, sexual and/or emotional abuse and physical and emotional neglect, higher scores indicate greater abuse/neglect. Completed by participant at baseline visit.
Time Frame
At Baseline
Title
The Revised Children's Anxiety and Depression Scale (RCADS)
Description
Measures anxiety and depression symptoms in children; higher scores indicate increased symptom severity. Completed by participant and parent. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
The Columbia Suicide Severity Rating Scale (C-SSRS)
Description
Measure that addresses the full range of suicidal thoughts and behaviors that suggest a person is at heightened risk of committing suicide. Completed by trained research study coordinator. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Time Frame
16 months
Title
Healthcare Related Stigma Questionnaire
Description
Measures stigma in patients and their parents related to their interaction with health care providers; higher scores indicate greater stigma. Completed by participant and parent. Assessed at baseline visit.
Time Frame
At Baseline
Title
COVID-19 Functional Neurological Disorders (FND) Questionnaire
Description
Assesses the effect of COVID-19 diagnosis in FND patients. Completed by Children. Assessed at baseline visit
Time Frame
At Baseline
Title
Flanker Inhibitory Control and Attention Subtest
Description
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures executive function and attention; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
4 months
Title
List Sorting Working Memory Subtest
Description
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures working memory; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
4 months
Title
Pattern Comparison Processing Speed Subtest
Description
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures processing speed; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
4 months
Title
Dimensional Change Card Sort Subtest
Description
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures executive function; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
4 months
Title
Picture Sequence Memory Subtest
Description
Subtest of the National Institute of Health Toolbox Cognition Battery. Measures episodic memory; higher scores indicate better performance. Completed by children. Assessed at 1st therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
4 months
Title
Sleep
Description
Objectively measured using Respironics Actiwatch Spectrum Pro and subjectively measured using sleep diaries. Worn/completed by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
4 months
Title
PNES Episode Severity
Description
Objectively measured using Respironics Actiwatch Spectrum Pro. Worn by children. Assessed for 1 week between baseline visit and 1st therapy session and 2 weeks between 11th therapy session and 1 week after 12th therapy session (about 4 months total).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 9-18 years old. Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG. Family member (parent if a minor) willing to participate and that the subject with PNES chooses. Exclusion Criteria: Comorbid Epilepsy Less than 4 PNES per month Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders) Participation in other therapy Severe intellectual disability Severe mental illness (delusions/hallucinations) Exclusion for CPT: Blood pressure >130/80 mmHg for adolescents greater than or equal to 13 years old Either systolic and/or diastolic blood pressure greater than or equal to 95% based on sex and age for children less than 13 years old
Facility Information:
Facility Name
Sparks Center Office of Psychiatric Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES

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